EDC platform review

Medidata Rave EDC review

Rave EDC is Medidata's cloud electronic data capture system for capturing, managing, cleaning and reporting clinical trial data, and it sits within the wider Medidata Platform. It is used mainly by pharmaceutical, biotech and medical device sponsors and CROs; Medidata's EDC page cites 38K+ studies and 1.8M+ users.

Facts checked: November 2026 · Rank 8 of 18 · How we rank

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Our score: 6.8/10
Best for: Large multinational Phase II-III drug trials
Pricing: Quote-based; Medidata describes a flexible pricing model
Vendor: Medidata (a Dassault Systèmes brand), New York City, USA

Unique feature

EDC unified with RTSM, eCOA and imaging

Medidata states that Rave RTSM is 'fully unified with Rave' as part of the same system, and that eCOA, eConsent and imaging data on the Medidata Platform reach Rave without separate reconciliation.

Fit

Who Medidata Rave EDC suits

Best for

Large multi-site Phase II-III drug trials run by sponsors or CROs
Global programmes wanting EDC, randomisation, eCOA and imaging from one vendor
Phase I, Phase IV or device post-market studies (via Rave Lite)

Less suited to

Small investigator-led studies that need published or low-cost pricing
Teams wanting inferential statistics inside the data capture tool
Projects that require a free or open-source option

Features

Key features

What the vendor documents publicly, checked against its own pages. “Not stated” means we could not confirm it, not that it is missing.

✓ Yes◐ Partly+ Add-on– No? Not stated

+Vendor builds your databaseMedidata Study Build Services; vendor cites 4-12 week builds
✓Build forms yourselfDrag-and-drop study design and global eCRF libraries
✓Audit trailField- and form-level audit history (EORTC user guide)
✓Electronic signaturesInvestigator signs eCRFs singly or in bulk (EORTC user guide)
✓Edit checks at data entryField and form edit checks; validation runs as each field is entered
✓Queries and source data verificationQuery handling in EDC; Targeted SDV for risk-based verification
+RandomisationRave RTSM, which vendor says is unified with Rave
+ePRO and participant self-entryMedidata eCOA; vendor says data syncs directly to Rave
+eConsentMedidata eConsent, a separate platform product
?Offline mobile data collection
?Forms in several languageseCOA cites 200+ languages; EDC form languages not stated
✓CDISC export (ODM / SDTM)CDISC ODM import and export (Rave Web Services release, 2008)
✓Built-in reports and dashboardsDashboards, standard and ad hoc reports, multi-dataset listings
?Built-in statistical analysis
?Numbered tables, figures and listings
✓APIRave Web Services API for system integrations
?Free or open-source optionPricing only via 'Contact Us'

Verdict

Strengths and limitations

Strengths

Broad integrated suite: RTSM, eCOA, eConsent, imaging and coding
Vendor states mid-study amendments run with no system downtime
G2 reviewers note integrations and handling of large datasets

Limitations

No published pricing
G2 reviewers mention cost for small companies and a learning curve
Randomisation, ePRO and eConsent are separate Medidata products

Details

Pricing, hosting and regulation

Pricing

Quote-based; Medidata describes a flexible pricing model. Published prices: not published. Pricing source.

Hosting and security

Hosting regions: not stated. Vendor-hosted cloud ('Medidata Clinical Cloud'); trust page references French HDS hosting and China data processing documentation. No self-hosting option stated.

Certifications: ISO 27001:2022 (vendor), ISO 27701:2019 (vendor), ISO 27017 and ISO 27018 statements of conformity (vendor), SOC 2+ Type II audit report, biannual (vendor), HDS French health data hosting certificate (vendor), CSA STAR registry entry (vendor).

Regulatory support

Vendor publishes position statements on 21 CFR Part 11, EU Annex 11 and ICH E6, and describes a 'robust GDPR compliance program'.. Whatever the software offers, your own procedures, validation and training are still needed for a regulated study.

Scale and set-up

Vendor says Rave supports trials from small rare-disease studies to Phase III studies with '10,000's of patients'; its EDC page cites 38K+ studies and 700K+ certified site users.. Built by the sponsor or CRO's study builders, or by Medidata Study Build Services (vendor cites 4-12 weeks). Vendor states AI reduces EDC setup time and amendments run with no downtime..

Alternatives

Sources (checked November 2026)